510(k) · Cleared
ClearedInfiniti 2C9 & VKORC1 Multiplex Assay for Warfarin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Autogenomics, Incorporated · ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Cleared on Jan 23, 2008 as substantially equivalent to K043576 (Roche Molecular Systems, Inc., 2005) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2004. 4 later devices descend from it.
- Decided
- Jan 23, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- ODW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN040011 (2004). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
- 1 generation backK043576 Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 2005 · Recalled
- This deviceK073014 Infiniti 2C9 & VKORC1 Multiplex Assay for WarfarinAutogenomics, Incorporated · 2008
- Descendant · cites it directly · 3 of its ownK101683 Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010
- Descendant · 2 generations on · 1 of its ownK123891 Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK220026 Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK120466 Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K101683Infiniti CYP2C19 AssayAutogenomics, Incorporated · 2010 · cites it directly3descendants
- K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013 · 2 generations on1descendant
- K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023 · 3 generations on0descendants
- K120466Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN040011 | Amplichip CYP450 Test, Model 04381866190 | Roche Molecular Systems, Inc. | 2004 | — |
| −1 | K043576 | Roche Amplichip CYP450 Test | Roche Molecular Systems, Inc. | 2005 | 1 |
| 0 (this device) | K073014 | Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin | Autogenomics, Incorporated | 2008 | — |
| +1 | K101683 | Infiniti CYP2C19 Assay | Autogenomics, Incorporated | 2010 | — |
| +2 | K123891 | Spartan RX CYP2C19 Test System | Spartan Bioscience, Inc. | 2013 | — |
| +3 | K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | 2023 | — |
| +2 | K120466 | Verigene CYP2C19 Nucleic Acid Tes (2C19) | Nanosphere, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043576 | Roche Amplichip CYP450 TestSummary page 2…tiplex Assay for Warfarin to those of the predicate devices * AmpliChip CYP450 Test for CYP2C19 (k043576) * INFINITI System Assay for Factor II & Factor V (k060564) Table a I… | 2005 |
| * | K060564 | Infiniti SystemSummary page 2…* AmpliChip CYP450 Test for CYP2C19 (k043576) * INFINITI System Assay for Factor II & Factor V (k060564) Table a I Predicate… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101683 | Infiniti CYP2C19 Assay | 2010 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K101683 (Autogenomics, Incorporated, 2010) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K043576.
How does its category compare?
All ODW devicesODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ODW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ODW
Too few ODW 510(k)s in any year since 2007 to give a median.
Recalls per year · ODW
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODW
No MAUDE report names ODW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is an in vitro diagnostic test for the detection and genotyping of the *2 and *3 CYP4502C9 genetic variants and the VKORC1 3673 (-1639) intronic variant in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.
The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is indicated for use to identify individuals at risk for sensitivity to warfarin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K073014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073014
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026